- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01521884
Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy
2015년 2월 3일 업데이트: Pfizer
Longitudinal Changes In Fatigue And Health Status (aims2) In Ra Patients Treated With Sc Anti-tnf-alpha Therapy
People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL.
In this study we are measuring the impact of SC biologics on these parameters.
연구 개요
상세 설명
Observational prospective study Purely descriptive
연구 유형
관찰
등록 (실제)
62
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Leuven, 벨기에, 3000
- UZ Gasthuisberg
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
patients seen in a rheumatology practice
설명
Inclusion Criteria:
Patients who:
- Are active RA patients (as judged by treating MD)
- Are 18 years of age or older at time of consent
- Are scheduled by their rheumatologist to initiate SC anti-TNF-α therapy + MTX
Exclusion Criteria:
Use of biologics (or any experimental drug) in the last 3 months before initiation of SC anti-TNF-α therapy.
Participation in other clinical or observational trials
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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RA Patients treated with SC anti-TNF
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SC anti-TNF
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline
기간: Baseline
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AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Baseline
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6
기간: Month 6
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AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Month 6
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12
기간: Month 12
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AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Month 12
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18
기간: Month 18
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AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Month 18
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24
기간: Month 24
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AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Month 24
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Visual Analog Scale (VAS) Fatigue Score
기간: Baseline, Month 6, 12, 18, 24
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Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
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Baseline, Month 6, 12, 18, 24
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Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)
기간: Baseline, Month 6, 12, 18, 24
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DAS28-ESR was calculated from the number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]).
Total score range: 0-10, higher score=more disease activity (DA).
DAS28-ESR less than equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high DA
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Baseline, Month 6, 12, 18, 24
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Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
기간: Baseline, Month 6, 12, 18, 24
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DAS28-CRP was calculated from the number of swollen joints ( SJC) and tender joints (TJC) count using 28 joint count and CRP (milligram per liter [mg/L]).
Total score range: 0-10, higher score= more disease activity.
DAS28 (CRP) : <3.2= low disease activity, >3.2 to 5.1 = moderate to high disease activity and less than (<)2.6 = remission.
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Baseline, Month 6, 12, 18, 24
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Health Assessment Questionnaire (HAQ) Total Score
기간: Baseline, Month 6, 12, 18, 24
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HAQ: 20-item participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities.
Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Overall score was computed as sum of item scores.
HAQ total score was 0 to 60 (as used in Belgium), where greater score indicated greater difficulty.
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Baseline, Month 6, 12, 18, 24
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score
기간: Baseline, Month 6, 12, 18, 24
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Spearman correlation coefficient between AIMS2 component score and VAS fatigue score (AIMS2 component score versus [vs] VAS fatigue) was calculated.
AIMS2 : 78-item questionnaire assessing 12 scales.
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and VAS score: Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
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Baseline, Month 6, 12, 18, 24
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Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR)
기간: Baseline, Month 6,1 2, 18, 24
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Pearson correlation coefficient between AIMS2 component score and DAS28-ESR score (AIMS2 component score vs DAS28-ESR) was calculated.
AIMS2: 78-item questionnaire assessing 12 scales.
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]).
Total score range: 0-10, higher score= more disease activity.
DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA.
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Baseline, Month 6,1 2, 18, 24
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Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale- Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
기간: Baseline, Month 6, 12, 18, 24
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Pearson correlation coefficient between AIMS2 component score and DAS28-CRP score (AIMS2 component score vs DAS28-CRP) was calculated.
AIMS2: 78-item questionnaire assessing 12 scales.
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L).
Total score range: 0-10, higher score= more disease activity.
DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission.
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Baseline, Month 6, 12, 18, 24
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Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR) and Visual Analog Scale (VAS) Fatigue Score
기간: Baseline, Month 6, 12, 18, 24
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Spearman correlation coefficient between DAS28-ESR and VAS fatigue (DAS28-ESR vs VAS score) was calculated.
DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]).
Total score range: 0-10, higher score= more disease activity.
DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA and VAS fatigue = Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
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Baseline, Month 6, 12, 18, 24
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Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) and Visual Analog Scale (VAS) Fatigue Score
기간: Baseline, Month 6, 12, 18, 24
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Spearman correlation coefficient between DAS28-CRP and VAS score (DAS28-CRP vs VAS score) was calculated.
DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L).
Total score range: 0-10, higher score= more disease activity.
DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission and VAS= Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
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Baseline, Month 6, 12, 18, 24
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 11월 1일
기본 완료 (실제)
2014년 2월 1일
연구 완료 (실제)
2014년 2월 1일
연구 등록 날짜
최초 제출
2011년 8월 19일
QC 기준을 충족하는 최초 제출
2012년 1월 30일
처음 게시됨 (추정)
2012년 1월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 2월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 2월 3일
마지막으로 확인됨
2015년 2월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
SC anti-TNF에 대한 임상 시험
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Assistance Publique - Hôpitaux de Paris알려지지 않은
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Fundación de Investigación Biomédica - Hospital...완전한
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University of California, San DiegoUniversity of Oklahoma; University of Southern California; Children's Bureau - Administration... 그리고 다른 협력자들완전한
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argenx모집하지 않고 적극적으로원발성 면역 혈소판 감소증미국, 프랑스, 그루지야, 독일, 이탈리아, 일본, 폴란드, 러시아 연방, 스페인, 칠면조, 영국, 아르헨티나, 호주, 불가리아, 칠레, 중국, 덴마크, 그리스, 아일랜드, 이스라엘, 요르단, 대한민국, 멕시코, 뉴질랜드, 노르웨이, 포르투갈, 루마니아, 세르비아, 남아프리카, 대만, 태국, 튀니지
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Immunicom Inc모병